Bristol-Myers Squibb said on Monday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended approval of an every four-week (Q4W) Opdivo (nivolumab) dosing schedule of 480 mg infused over 60 minutes as an option for patients with advanced skin cancer and previously treated kidney cancer.
The CHMP also recommended approval of a two-week (Q2W) Opdivo dosing option of 240 mg infused over 30 minutes to replace weight-based dosing for all six approved monotherapy indications in the EU, BMS said, noting that the CHMP recommendation will now be reviewed by the European Commission (EC), for the EU approval.
Fouad Namouni, head of development, Oncology, Bristol-Myers Squibb said that the company will be waiting waht the EC has to say after the positive CHMP opinion.